A Cohort IND Expanded Access Program for Supporting Patient Access to Tebentafusp
ConditionUveal Melanoma
Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
Age18+
SponsorImmunocore Ltd
About this trial
This Expanded Access Program aims to:
1. Provide access to tebentafusp for mUM patients. 2. Provide access to tebentafusp for patients, who were on the control arm of the randomized controlled Phase II trial (IMCgp100-202) and were unable to crossover during the specified window. 3. Ensure that patients, who are benefiting from tebentafusp treatment while participating in an ongoing Immunocore sponsored clinical study (e.g., IMCgp100-102 or IMCgp100-201), may continue tebentafusp treatment on this Programme once the ongoing trial has met all of its key primary and secondary objectives.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female patients age ≥ 18 years of age at the time of first dose
Histologically or cytologically confirmed metastatic UM or unresectable UM patients
HLA-A*02:01 positive
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Disqualifiers
Treated CNS lesions must be radiographically stable for ≥ 2 weeks after intervention (surgery and/or radiation).
Participants must be neurologically stable off systemic corticosteroids for at least 2 weeks prior to first planned administration of tebentafusp.
Cellular therapies (e.g., T-cell therapies): 90 days.
Cytotoxic T-lymphocyte-associated protein 4 (CTLA-4)- targeted immunotherapies (e.g., ipilimumab): 28 days
Trial design
Treatments tested in this trial
Tebentafusp
DrugConcentrate solution for intravenous infusion
Treatment groups
No treatment groups listed
Trial outcomes
This trial has no outcomes listed.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Immunocore Ltd
Lead sponsor
Clinigen, Inc.
Collaborator
Source ClinicalTrials.gov